FDA Adverse Event
Other
Summary report: N
ACUMED MAYO CLINIC CONGRUENT BONE PLATE SYSTEM
MDR report key: 624848
·
Received August 3, 2005
Report
- Report Number
- 3025141-2005-00004
- Event Type
- Other
- Date Received
- August 3, 2005
- Date of Event
- July 6, 2005
- Report Date
- August 3, 2005
- Manufacturer
- ACUMED
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BROKEN PLATE FOLLOWING NON-UNION. DATES NOT KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUMED MAYO CLINIC CONGRUENT BONE PLATE SYSTEM | BONE PLATE | HRS | ACUMED | PL-ELOX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |